Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay North Dock, Dublin, D01 V4A3, Ireland
Inegy 10 mg / 20 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white capsule-shaped tablets with code “312” on one side. |
Each tablet contains 10 mg ezetimibe and 20, 40 or 80 mg of simvastatin.
Excipient(s) with known effect:
Each 10/20 mg tablet contains 126.5 mg of lactose monohydrate.
Each 10/40 mg tablet contains 262.9 mg of lactose monohydrate.
Each 10/80 mg tablet contains 535.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ezetimibe |
Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol. The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of cholesterol. |
|
| Simvastatin |
Simvastatin has a potent activity in inhibiting HMG-CoA reductase (3-hydroxy–3-ethylglutaryl-CoA-reductase). Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations. |
|
| Simvastatin and Ezetimibe |
Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Ezetimibe and simvastatin are two lipid-lowering compounds with complementary mechanisms of action. Ezetimibe/simvastatin combination reduces elevated total cholesterol (total-C), LDL-C, apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and increases high-density lipoprotein cholesterol (HDL-C) through dual inhibition of cholesterol absorption and synthesis. |
| List of Excipients |
|---|
|
Butylated hydroxyanisole |
White HDPE bottles with foil induction seals, white child-resistant polypropylene closure, and silica gel desiccant, containing 100 tablets.
Push-through blisters of opaque polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium in packs of 90 tablets.
Push-through blisters of opaque polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium in packs of 7, 10, 14, 28, 30, 50, 56, 84, 98, 100, or 300 tablets.
Unit dose push-through blisters of opaque polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium in packs of 30, 50, 100, or 300 tablets.
Not all pack sizes may be marketed.
Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay – North Dock, Dublin, D01 V4A3, Ireland
PA23198/024/002
Date of first authorisation: 3rd December 2004
Date of last renewal: 2nd April 2014
| Drug | Countries | |
|---|---|---|
| INEGY | Austria, Cyprus, Germany, Spain, France, Croatia, Ireland, Italy, Netherlands, Poland, United Kingdom, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
